Medication-Coated Stent May Reduce Reblockage in Arteries

Texas Heart Institute and St. Luke's Episcopal Hospital physicians announced April 6 that they are the first in Texas to begin human clinical trials evaluating the efficacy of medicine-coated stents to reduce the renarrowing of arteries, medically known as restenosis.

"The development of the stent itself was a significant milestone in the treatment of blocked coronary arteries, but the problem of restenosis has continued to be an issue," said Dr. Emerson C. Perin, director of New Cardiovascular Interventional Technology at the Texas Heart Institute at St. Luke's and a principal investigator in the study. "If this new procedure proves successful, it could revolutionize interventional cardiology."

Stents are small, metallic, mesh-like tubes designed to support plaque-damaged arterial walls after a blockage has been removed, usually through balloon angioplasty. As many as 25 percent of patients who received a stent experience a renarrowing of the stented area, which is most likely caused by the buildup of scar tissue.

The stents under evaluation in this study are coated with a pharmaceutical agent known as sirolimus, a potent immunosuppressive medication approved by the Food and Drug Administration for prevention of organ rejection following renal transplantation. It is hoped sirolimus-coated stents will prevent local cell replication and deter the scar tissue from forming.

The initiation of this study follows two other clinical trials performed in Brazil and in The Netherlands.

"Follow-up assessment of patients in these foreign trials showed remarkable results," said Dr. Perin. "Twelve-month follow up of 30 Brazilian patients revealed no evidence of in-stent or edge restenosis. The 15 patients in The Netherlands showed similar results after six months."

The Texas Heart Institute and St. Luke's are among 55 centers across the country enrolling up to 1,100 patients in this randomized, double-blinded study sponsored by Cordis, a Johnson & Johnson company. Cordis received approval from the FDA in early February to conduct the trials under an initial investigational device exemption.

Other Texas Heart Institute at St. Luke's physicians participating in this study include Drs. Arup Achari, Eduardo Hernandez, Ali Mortazavi, Mark J. Schnee, and James M. Wilson.

---

©2006 Texas Medical Center

---

E-Mail: tmcinfo@texmedctr.tmc.edu
URL: http://www.tmc.edu/tmcnews/05_01_01/page_11.html